A recent study published in the Annals of Internal Medicine found that many heart devices recalled due to safety issues had limited or no clinical testing before approval. Researchers examined cardiovascular devices with Class I recalls—the most serious level—issued between 2013 and 2022. They found that of 157 recalled devices, only 30 had undergone premarket clinical testing.
Most devices were cleared through the FDA’s 510(k) pathway, which only requires demonstrating that the device is similar to an existing one, rather than undergoing rigorous clinical trials. The study highlighted that 71% of the recalled devices went through this moderate-risk pathway, while only a minority went through the more stringent premarket approval (PMA) process for high-risk devices like defibrillators and stent grafts.
The most common cause of recall was design flaws, accounting for 31% of the cases, and many of the recalls recommended halting the device’s use, with one even advising its removal. The study also noted that the clinical tests conducted were often weak, lacking randomized trials, control groups, and reliable clinical endpoints.
The researchers proposed that regulatory bodies like the FDA should strengthen requirements for premarket testing and postmarket follow-up, especially for devices with high recall rates. They also pointed out the need for more comprehensive data in the FDA’s recall database, as key information was missing in many cases.
This study, conducted by leading academic institutions, sheds light on the gaps in safety testing for heart devices and suggests ways to improve patient safety by tightening regulatory oversight